Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Catheter Connections, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time
235 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142806DualCapCatheter Connections, Inc.2015-05-222350
K142399DualCap IV Pole Strips(Disinfectant Caps for Male Luers)Catheter Connections, Inc.2014-11-19840
K123967CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERSCatheter Connections, Inc.2013-01-22270
K123065CATHETER CONNECTIONS DUALCAP SOLOCatheter Connections, Inc.2012-12-14741
K113842CATHETER CONNECTIONS' DUALCAP SOLOCatheter Connections, Inc.2012-01-27300
K112985CATHETER CONNECTIONS' DUALCAP DUOCatheter Connections, Inc.2011-11-09340
K093229CATHETER CONNECTIONS DUALCAPCatheter Connections, Inc.2010-04-081760

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda